AquaShape LipoCollector™ Instructions for use

Human Med AG
Instructions for use and processing of the LipoCollector TM
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Vers./Date:
10 of 20
1 / 15.07.2008
12. All other surfaces must then be cleaned with the 10 mm brush.
Pre-cleaning with the brushes must be carried out using the cleaning and disinfecting
solution (Gigasept Instru AF, 1.5%, made up with lukewarm water, demineralised
water if possible).
These steps must be repeated until the brushes and the surfaces and cavities to be
cleaned are free of visible contamination.
The instrument cleaning solution must be renewed at least daily or if there is visible
contamination.
13. Cleaning and
disinfection:
ATTENTION!
14. Drying:
15. Maintenance:
16. Packing:
17. Sterilisation:
18. Storage:
All parts must now be completely immersed in an ultrasound bath with cleaning and
disinfecting solution (Gigasept Instru AF, 3%, made up with lukewarm water,
demineralised water if possible). The cleaning process in the ultrasound bath must be
at least 5 minutes long.
Cleaning for 15 minutes in an immersion bath is also possible. In this case the same
cleaning solution and the same temperature are required.
Do not mix with other cleaners.
After cleaning in the solution the parts must be thoroughly rinsed with running water
(preferably demineralised) or in a rinsing bath for at least 1 minute.
Repeat rinse step again.
Dry all parts inside and out with sterile compressed air.
Maintenance of the individual parts is not intended.
The dried individual parts of the LipoCollector TM must be packed as follows in
suitable sterile packaging suitable for steam sterilisation as per ISO 11607. The
package must be large enough that the seal is not under tension.
1. Container insert separately
2. Lid separately
3. Retaining ring, perforated metal plates and reducer together
4. Collection container separately
Steam sterilisation using a fractionated vacuum procedure at 121°C for at least 15
minutes and at 134°C for 3 minutes is validated.
Sterilisation at 134°C for at least 10 minutes was tested with no negative effects on
the material detected.
For every sterilisation check the pressure protocol for the particular steriliser to ensure
compliance with the necessary parameters.
The individual sterile foil bags must be stored in a closed cupboard protected from
dust, moisture and large temperature fluctuations.
The shelf life is determined by the specifications for the sterile packaging used.